Sieper Joachim, Rudwaleit Martin, Lenaerts Jan, Wollenhaupt Jürgen, Myasoutova Leysan, Park Sung-Hwan, Song Yeong W, Yao Ruji, Huyck Susan, Govoni Marinella, Chitkara Denesh, Vastesaeger Nathan
Department of Gastroenterology, Infectiology, and Rheumatology, Charité, University Medicine Berlin, Berlin, Germany
Department of Gastroenterology, Infectiology, and Rheumatology, Charité, University Medicine Berlin, Berlin, Germany.
Rheumatology (Oxford). 2016 Nov;55(11):1946-1953. doi: 10.1093/rheumatology/kew230. Epub 2016 Jul 13.
To evaluate partial remission during treatment with infliximab (IFX) + naproxen (NPX) vs NPX alone in patients from the two subgroups of SpA and explore baseline predictors of partial remission.
Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial was a double-blind, randomised controlled trial of IFX in biologic-naïve patients with early, active axial SpA. Patients were randomised (2:1) to receive 28 weeks of treatment with i.v. IFX 5 mg/kg (weeks 0, 2, 6, 12, 18 and 24) + NPX 1000 mg/day or i.v. placebo (PBO) + NPX 1000 mg/day. The current post hoc analysis evaluated outcomes in patients who did or did not meet modified New York radiographic criteria for AS.
The analysis included 94 patients who met AS criteria and 56 with non-radiographic axial SpA (nr-axSpA). At week 28, Assessment of SpondyloArthritis international Society (ASAS) partial remission was greater with IFX + NPX than PBO + NPX for both the AS group (70.5 vs 33.3%, respectively) and the nr-axSpA group (50.0 vs 37.5%, respectively). A similar pattern occurred with several efficacy measures. Larger treatment effects occurred in the AS group than the nr-axSpA group, possibly due to baseline differences in disease characteristics. Multivariable analyses identified the type of treatment, age and HLA-B27 status as predictors of ASAS partial remission in the total study population. MRI sacroiliac joint scores were associated with partial remission during IFX + NPX treatment.
Patients with AS had greater partial remission with IFX + NSAID than NSAID therapy alone; patients with nr-axSpA had a smaller treatment effect. Baseline disease characteristics and age were associated with partial remission with IFX therapy.
评估英夫利昔单抗（IFX）+萘普生（NPX）与单独使用NPX治疗脊柱关节炎（SpA）两个亚组患者期间的部分缓解情况，并探索部分缓解的基线预测因素。
英夫利昔单抗作为早期活动性轴向脊柱关节炎患者的一线治疗试验是一项针对初治的早期、活动性轴向SpA生物制剂-naïve患者的IFX双盲、随机对照试验。患者被随机分组（2:1），接受静脉注射IFX 5mg/kg（第0、2、6、12、18和24周）+NPX 1000mg/天或静脉注射安慰剂（PBO）+NPX 1000mg/天，为期28周的治疗。当前的事后分析评估了符合或不符合改良纽约AS影像学标准的患者的结局。
分析纳入了94例符合AS标准的患者和56例非放射性轴向SpA（nr-axSpA）患者。在第28周时，AS组（分别为70.5%和33.3%）和nr-axSpA组（分别为50.0%和37.5%）中，IFX+NPX组的脊柱关节炎国际协会（ASAS）部分缓解率均高于PBO+NPX组。几种疗效指标也出现了类似的模式。AS组的治疗效果大于nr-axSpA组，这可能是由于疾病特征的基线差异所致。多变量分析确定治疗类型、年龄和HLA-B27状态是整个研究人群中ASAS部分缓解的预测因素。MRI骶髂关节评分与IFX+NPX治疗期间的部分缓解相关。
AS患者接受IFX+非甾体抗炎药（NSAID）治疗的部分缓解率高于单独使用NSAID治疗；nr-axSpA患者的治疗效果较小。基线疾病特征和年龄与IFX治疗的部分缓解相关。
